NCT02029586终止2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, 12 Weeks, Therapeutic Exploratory Phase 2 Clinical Study to Evaluate the Safety and Efficacy of MB12066 in Patients With Nonalcoholic Fatty Liver Disease (NAFLD) Except Cirrhosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 10
- 主要终点
- Change in hepatic steatosis(%)
研究概览
简要总结
This is a controlled study to determine the effectiveness and safety of MB12066 in the treatment of adult patients with Nonalcoholic Fatty Liver Disease(NAFLD) except cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •NAFLD Activity Score(NAS) ≥ 3 (Biopsy-proven)
排除标准
- •Alcohol consumption > 20g/day
- •Type 1 diabetes or poorly controlled diabetes mellitus (HbA1c ≥ 9%)
- •Evidence of other chronic liver disease (e.g. HBsAg positive, anti-HCV positive, autoimmune hepatitis, Wilson's disease, alpha-1 antitrypsin deficiency and etc.)
- •ALT, AST > 5X the upper limit of normal
- •Serum creatinine ≥ 2mg/dl
- •Fibrosis score ≥ 3 according to the NASH CRN fibrosis staging system
- •NQO1 T/T type
- •Weight loss of more than 5kg within 6 months
- •Bariatric surgery within 6 months
- •Known alcohol or any other drug abuse in the last five years
- •Insulin sensitizers, hepatoprotective agents, anti-oxidants, lipid-lowering agents, drugs induced fatty liver within 1 month
研究组 & 干预措施
MB12066
Experimental
干预措施: MB12066 200mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in hepatic steatosis(%)
时间窗: baseline, 12 weeks
The NAFLD Activity Score (NAS) grades NAFLD on liver biopsy based on the individual scoring of steatosis, inflammation and ballooning. The NAS is assessed on a scale of 0 to 8 with higher scores indicating more severe disease and lower scores indicating less severe disease. NAS is obtained by adding steatosis(assessed on a scale of 0 to 3), inflammation (assessed on a scale of 0 to 3) and ballooning (assessed on a scale of 0 to 2).
次要结局
- Change in steatosis score(baseline, 12weeks)
- Proportion of subjects with more than 1 point in total NAFLD Activity Score (NAS)(baseline, 12 weeks)
- Change in fibrosis score(baseline, 12 weeks)
- Change in lipid profile(baseline, 4weeks, 8weeks, 12weeks)
- Change in lobular inflammation score(baseline, 12weeks)
- Change in ballooning score(baseline, 12weeks)
研究者
研究点 (10)
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